Debbie Stabenow

Devices & Diagnostics

Minnesota senators recruit buddies to pressure FDA over 510(k)

Minnesota Sens. Amy Klobuchar and Al Franken along with Rep. Erik Paulsen have championed the medical device industry, giving speech after speech and writing letter after letter to the Food and Drug Administration about upcoming changes to its 510(k) approval program. I doubted the campaign would do much. But Wednesday, a bipartisan group of 15 senators sent a letter to FDA Commissioner Dr. Margaret Hamburg urging her agency, among other things, to adopt a more deliberate, cautious approach to amending 510(k).